Zyno Medical Z-800 User manual

Z-800 Instructions for Use. 1/69
P/N 800-600-01-08 Rev 08/10
Z-800 Infusion Pump
INSTRUCTIONS FOR USE
Revised 08/2010
Zyno Medical LLC
9 Tech Circle
Natick, MA, 01760
1-508-650-2008
Fax: [phone]
Web: www.zynomedical.com

Z-800 Instructions for Use. 2/69
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WARNING:
Only use Zyno Medical provided IV sets with the Z-800 pump. There are risks associated
with using any IV sets other than Zyno Medical sets with this device. Zyno’s warranty for
its device will be null and void and Zyno will assume no responsibility for any incidents
that may occur if the device is not utilized strictly in accordance with its product labeling.
SAFETY STANDARD
The Z-800 infusion pump meets all safety standards for medical electrical devices,
corresponding to IEC 60601-1 and IEC 60601-2-24.

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TABLE OF CONTENTS
INTRODUCTION
About the Device ……………………………………………...………………………..
4
Features …………….…………………………………….……………………………..
5
Symbols ...........................................................................................................................
6
GETTING STARTED
Warnings & Cautions........................................................................................................
7
Device Description ...........................................................................................................
9
Installation Procedure …………………………………………………………………...
12
Preparing An Infusion …………………………………………………………………..
13
Loading Primary Administration Set …………………………………………………...
14
Continuous Mode Infusion …………………………………………………….………..
16
Time/VTBI Programming ………………………………………………………………
24
Infusion Complete ………………………………………………………………………
26
10 STEP Mode Infusion ……………………………………………………….………..
27
TPN Mode Infusion …………………………………………………...………………...
29
Intermittent Mode..............................................................................................................
31
Blood Mode.......................................................................................................................
34
Prime IV Set Using PRIME Key......................................................................................
36
Powering Off ...................................................................................................................
39
Changing the Primary Solution Container .......................................................................
40
Changing & Reloading an IV Set During Infusion ..…...……..………..……………….
41
Protocol Mode Infusion………………………………………………………………….
42
Save Infusion Parameters as a Protocol …..…………………...…………...…………...
43
ALARMS AND TROUBLESHOOTING
Definition ……………......................................................................................................
44
Alarms ..............................................................................................................................
45
Warnings ………………..................................................................................................
46
Errors ………………........................................................................................................
48
MAINTENANCE
Specifications ...................................................................................................................
48
Configurable Settings .......................................................................................................
50
Storage ..............................................................................................................................
55
Battery Care and Maintenance ..…...................................................................................
56
Cleaning ……...................................................................................................................
59
Inspection Requirements...................................................................................................
60
Service Information ..........................................................................................................
61
Warranty............................................................................................................................
62
APPENDIX
Alarm Testing Procedure ..................................................................................................
63
Approved Administration Sets .........................................................................................
67

Z-800 Instructions for Use. 4/69
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INTRODUCTION
ABOUT THE DEVICE
The Z-800 Infusion pump is intended to provide accurate
delivery of parenteral fluids, blood and blood products to a
human patient when administered by a qualified health care
professional.
User Qualification
The Z-800 infusion pump is intended for use at the direction
or under the supervision of licensed physicians or certified
healthcare professionals who are trained in the use of the Z-
800 infusion pump and the administration of parenteral fluids
and drugs, blood and blood products. This training should
emphasize patient safety and prevention of error.
This document provides directions for use of the Z-800
infusion pump. To ensure safe usage, please read the entire
instruction manual before using the device.
The Z-800 infusion pump must only be operated utilizing
Zyno Medical’s proprietary administration sets. The sets are
designed for use with the Z-800 pump as well as for gravity-
flow stand-alone use. For specific administration set
instructions, refer to the Directions For Use provided with the
set. For priming and loading instructions, refer to ―Loading a
Primary Administration Set‖ and ―Loading a Secondary
Administration Set‖ sections of this document.
Contraindication: None known.

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INTRODUCTION
FEATURES
Flow Rates
The Z-800 flow rate range is from 1 to 999 ml/h.
Free Flow Protection
Z-800 Pump has a built in free flow clamp to prevent
inadvertent free flow when the set is loaded in the pump.
WARNING: Some Z-800 IV sets configurations do
NOT have set based free-flow protection. Make sure to
close roller clamp before removing administration set
from Z-800 pump.
Occlusion Pressure
The Z-800 Pump provides 14 levels adjustable
downstream occlusion alarm thresholds between 4 psi to
30 psi.
Secondary Infusions
Secondary infusions may be delivered at a specified
secondary delivery rate and secondary volume-to-be-
infused (VTBI) independent of the primary infusion
parameters. When secondary VTBI is greater then zero,
the pump will always execute secondary infusion first.
Automatic changeover occurs to the primary infusion
parameters when the secondary infusion is complete. A
Zyno Medical proprietary primary administration set
with a back check valve must be used.
System Configuration
The system configuration mode provides the ability for
qualified personnel to customize device settings.
Tamper Resist
The Tamper Resist feature provides a quick, one touch
lockout of the front keypad.
Volume-To-Be-Infused
(VTBI)
The volume-to-be-infused (VTBI) range is from 1 to
9999 ml in 1 ml increments.

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INTRODUCTION
SYMBOLS
Canadian and U.S. Certification Mark: Products bearing this
mark have been tested and certified in accordance with
applicable U.S. and Canadian electrical safety and performance
standards (CSA C22.2 No. 601.1, UL 2601-1 and IEC 60601-2-
24).
Electrical Shock Protection Rating: Type BF.
IPX1
Protection against fluid ingress: Drip Proof.
Attention: Refer to accompanying documentation.
Rx Only
Federal (U.S.A) law restricts this device to sale by or on the
order of a physician.
Ground Pole. Potential Equalization Conductor (PEC). Note: If
the integrity of the PEC or Hospital Earth System is in question,
operate the instrument using internal battery power.

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GETTING STARTED
WARNINGS & CAUTIONS
The following Warnings and Cautions should be strictly followed to avoid harm to patients
and pump operators:
WARNING: Zyno Medical assumes no responsibility for incidents that may occur
if its product is not used in accordance with its product labeling.
WARNING: Only use Zyno Medical provided IV sets in the Z-800 pump.
WARNING: The Z-800 pump operation is strictly limited to trained operators
whose competency in safe Z-800 pump operation and safe IV therapy practices has
been tested and proven.
WARNING: Make sure the pump is stable by fastening securely to an IV pole, or
resting on a flat surface. IV poles vary in quality and stability. Avoid fastening the
pump too high on the pole, and test for stability before using.
WARNING: Prior to use, always verify the proper function of the display, audible
and visual alarms.
WARNING: Verify there are no kinks in the tubing when loading into the pump.
WARNING: Always read and follow the instructions that accompany the fluid
container and IV administration sets you are using. Carefully follow the
instructions in this document for loading, removing, and reloading the IV set.
Adjust the pumping section of the IV set every 24 hours, and replace the IV set at
least every 72 hours.
WARNING: To prevent free flow, make sure to load the IV set in the pump before
connecting the IV set to patient.
WARNING: To prevent free flow, make sure to disconnect the IV set from patient
before unloading the IV set from the Z-800 pump.
WARNING: Disconnect IV set from the patient before purging air bubbles out of
IV tubing.
WARNING: Some Z-800 IV sets configurations do NOT have set based free-flow
protection. Make sure to close roller clamp before removing administration set from
Z-800 pump.
WARNING: Do not over-program VTBI. Program the actual amount of the fluid
in the IV bag.

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GETTING STARTED
WARNINGS & CAUTIONS (Continued)
CAUTION: Please read the entire contents of this manual before using the Z-800 pump.
CAUTION: USA Federal and Canadian laws restrict this device to sale by or on the
order of a physician.
CAUTION: No user serviceable parts inside. Refer all service, repair, and calibration
to qualified technical personnel. Do not make unauthorized modifications.
CAUTION: To avoid mechanical or electronic damage, do not steam, autoclave or
immerse the pump in any fluids or cleaning solutions, and do not spray such fluids
directly on the pump. Always disconnect electrical power cord from outlet before
cleaning to prevent electrical shock. The IPX1 rating means that the pump is protected
against vertical dripping water.
CAUTION: Do not attempt to infuse two fluids simultaneously using the Z-800
infusion pump.
CAUTION: Operating Z-800 infusion pump near equipment that radiates high-energy
radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular
telephones, etc.) may cause false alarm conditions. If this happens, reposition the
device away from the source of interference or use an appropriate clinical alternative.
CAUTION: Always verify displayed infusion parameters (Primary Rate, Primary
VTBI, Secondary Rate, Secondary VTBI) against prescription before starting infusion.
GETTING STARTED
WARNING: After starting an infusion, make sure drops are falling in the drip
chamber. If no drops are falling, make sure the roller clamp is open. If the roller clamp
is open and still no drops are falling, replace and dispose of the IV administration set.
WARNING: The air detector cannot recognize the introduction of air at 3-way
stopcocks, infusion ports, and other lines/tubes below the pump.
WARNING: Do not operate this device in the presence of flammable anesthetics
mixture with air or oxygen or nitrous oxide.
WARNING: Do not expose Z-800 pump to X-Rays, gamma rays or other radiation, or
to strong electric or magnetic fields.
WARNING: The factory default settings should be used unless qualified clinical
personnel determine that other customized settings are appropriate and safe.

Z-800 Instructions for Use. 9/69
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DEVICE DESCRIPTION
Pump Front View –Door Closed

Z-800 Instructions for Use. 10/69
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GETTING STARTED
DEVICE DESCRIPTION (Continued)
Pump Front View - Door Open